UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006683 |
|---|---|
| Receipt number | R000007895 |
| Scientific Title | Open-label trial of ramelteon for sleep disorder with diabetes mellitus |
| Date of disclosure of the study information | 2011/11/07 |
| Last modified on | 2018/10/10 22:12:54 |
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Basic information
Public title
Open-label trial of ramelteon for sleep disorder with diabetes mellitus
Acronym
Ramelteon trial for sleep disorder with diabetes
Scientific Title
Open-label trial of ramelteon for sleep disorder with diabetes mellitus
Scientific Title:Acronym
Ramelteon trial for sleep disorder with diabetes
Region
| Japan |
Condition
Condition
Diabetes mellitus with sleep disorder
Classification by specialty
| Endocrinology and Metabolism | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of ramelteon for diabetes mellitus with sleep disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of sleep
Values for DM
Key secondary outcomes
Sleep diary
Change of DM medication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ramelteon
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type II diabetes mellitus with sleep disorder
Key exclusion criteria
On fluvoxamine
Intractable diabetes mellitus
Pregnancy
Ramelteon sensitivity
Severe brain disease
Severe somatic disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Meiyo Tamaoka |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Department of Sleep Madulatory Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
meiyou2.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mizue Hobo |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Department of Sleep Madulatory Medicine
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-3813-6111
Homepage URL
hobo-psy@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 07 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007895
